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A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
RECRUITINGPhase 3Sponsored by Incyte Corporation
Actively Recruiting
PhasePhase 3
SponsorIncyte Corporation
Started2026-04-09
Est. completion2028-09-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations66 sites
View on ClinicalTrials.gov →
NCT07522073
Summary
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation * No prior systemic treatment in the metastatic setting * ECOG Performance status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with any KRAS inhibitor * Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug * Known active CNS metastases Other protocol-defined Inclusion/Exclusion Criteria may apply.
Conditions2
CancerSolid Tumors
Interventions2
Locations66 sites
Investigative Site US058
Birmingham, Alabama, 35233
Investigative Site US016
Anchorage, Alaska, 99508
Investigative Site US026
Investigative Site US051
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Actively Recruiting
PhasePhase 3
SponsorIncyte Corporation
Started2026-04-09
Est. completion2028-09-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations66 sites
View on ClinicalTrials.gov →
NCT07522073